Biosimilar Medicines Research Articles

Advantages of biological analogues in blood glucose control of diabetes from a clinical perspective

This study aims to explore the clinical advantages of biosimilar drugs in blood glucose control of diabetes, and analyze the challenges and coping strategies. This paper discusses the advantages of biosimilars through a review. The analysis reveals that biosimilar drugs have significant cost-effectiveness, improved patient affordability, and ease of clinical use in diabetic glycemic control. At the same time, through education, monitoring and scientific conversion strategies, the challenges of doctors and patients, immunogenicity and safety monitoring can be overcome. Biosimilar drugs have important clinical value in the field of diabetes treatment, which provide new perspectives and methods for improving the treatment effect, improving the quality of life of patients, and optimizing the allocation of medical resources. Medical professionals, patients, and policy makers should work together to promote the rational application of biosimilar medicines.

US Trends In Anticancer Medicine Pricing And The Impact Of Competition, 2014-20.

Prices of anticancer medicines (including chemically synthesized medicines and biologics manufactured from living organisms) are a subject of concern, as they contribute to spending by health plans and patients. We describe prices and evaluate the impact of competition among 185 anticancer medicines, using IQVIA data from the period October2014-February2020. We calculated the price of each medicine, defined as volume-weighted wholesale costs net of prompt-pay discounts and gross of rebates, without and with inflation adjustment, and summarized them by patent status, formulation, and therapeutic class. We evaluated the relationship between prices and competition, using regression analyses. We also conducted event studies of the impact of generic entry on the prices of three medicines from distinct clinically relevant therapeutic classes. Over the course of the study period, medicine prices increased among brand-name products and decreased among generics and biosimilars. After exclusivity loss, generic and biosimilar medicine prices decreased, whereas brand-name prices remained stable. Event study results present more divergent price trends after exclusivity loss. Consistent with previous research, our study showed that competition may improve the affordability of medicines for payers and patients. However, this effect is limited for anticancer medicines because only a minority are available as generics and biosimilars.

Establishing a biologics and biosimilars committee/network: assessing educational requirements of pharmacy and other healthcare professionals

Abstract Introduction Successful professional networking involves shared, mutually beneficial interactions between individuals and/or individuals and groups1. Biologics and biosimilar medicines prescribing is rapidly evolving with an increasing number of clinical indications in healthcare2,3. Despite their importance, the absence of a structured national network dedicated to these complex therapies has left a gap in professional education and resource sharing among pharmacists. Recognising the necessity for a cohesive support system, this work explores the learning and professional needs of pharmacists regarding biologics and biosimilars and the potential development of a national pharmacy network to address these gaps. Aim The survey aimed to explore the educational needs and preference for a network and/or committee for pharmacy and other healthcare professionals focused on biologics and biosimilars medicines. Methods An electronic survey was developed and deployed for pharmacy and other healthcare professionals involved in the management of biologics and biosimilars via email cascade and social media, 12th February - 6th March 2023. The survey explored the preferred structure of the proposed group; formal committee and/or informal network, what the group would deliver, and any educational needs for members. The survey included questions about the respondent’s roles, sectors of work, regions and their clinical area(s). The open text responses were themed. The NHS health Research Authority tool was used to identify this project as service improvement and development, therefore did not require ethical approval. Results The responses received were from 46 pharmacists, 1 pharmacy technician, 15 doctors and nurses and 4 participants whose roles were unknown, working across multiple sectors; hospital, community, industry, and academia with representation from the devolved nations (n=3) and internationally (n=1). Most respondents expressed a need for a dedicated network and committee n=52 (79%), n=10 (15%) formal network, and n=4 (6%) informal committee. Common themes in response to what the group should deliver and educational needs included; harmonisation of approaches to guidelines and policies, pathway design, reduction in unwarranted variation (68%); platform to share new ideas, knowledge and peer advice (44%); strategy and leadership in service delivery and promotion of best practice and cost training, horizon scanning (29%); working collaboratively to produce multi-centre research projects (24%); to create a structured training programme for health care professionals (9%). Discussion/Conclusion The survey results highlight a gap in the current educational and professional support systems for PP’s concerning biologics and biosimilar medicines. The identified learning needs point to a strong demand for a structured network that can provide targeted education, share best practices and facilitate professional networking. The expertise within the group can also create formal eLearning programmes for healthcare professionals. This work serves as a foundational step towards the development this network, highlighting the critical areas of focus and the collective interest of the pharmacy community in bridging these gaps. The network should also facilitate communication and collaboration across different sectors, fostering a more cohesive and informed pharmacy community. Such an innovative network would not only enhance individual competency but also contribute to the overall advancement of pharmaceutical care in this specialised area.

Biosimilar Medicines: From Development Process to Marketing Authorization by the EMA and the FDA

Biosimilars are a new category of medicines that have revolutionized the treatment of patients with life-threatening conditions, such as cancer and autoimmune diseases. A biosimilar is a biological product that is very similar to an already approved biological medicine that is used as its reference. These medicines go through less clinical studies than their reference product and therefore the cost of their development process is significantly lower, giving patients access to them more quickly and at a more affordable price. However, due to the structural complexity and inherent degree of variability of these products, it is very difficult to develop biosimilar medicines that are exactly the same as the reference product. Thus, it is extremely important to define strict controls to guarantee that these minor differences are not clinically significant in terms of safety and efficacy. Like any other medicine, biosimilars have to go through a complex approval process, which involves a thorough assessment by regulatory authorities to ensure these products meet the necessary standards of quality, safety, and efficacy before being placed on the market. Due to their nature and complexity, the approval process of biosimilar medicines contains some unique and specific considerations. This review aims to address the regulatory framework of biosimilar medicines, their development process and the approval requirements by the European Medicines Agency (EMA) and the Food and Drug Administration (FDA).

Barriers and Enablers Affecting the Uptake of Biosimilar Medicines Viewed Through the Lens of Actor Network Theory: A Systematic Review.

Biosimilars represent an opportunity to realise savings against the costs of innovative medicines. Despite efforts made by stakeholders, there are numerous barriers to the uptake of biosimilars. To realise the promise of biosimilars reducing costs, barriers must be identified, understood, and overcome, and enablers magnified. The aim of this systematic reviewis to summarise the enablers and barriers affecting uptake of biosimilars through the application of a classification system to organise them into healthcare professional (HCP), patient, or systemic categories. A systematic literature search was performed in PubMed, Scopus, CINAHL, eConlit, and Embase. Included were primary research studies published in English between Jan 2017 through June 2023 focused on enablers and barriers affecting uptake of biosimilars. Excluded studies comprised comparisons of biosimilar efficacy and safety versus the reference biologic. One reviewer extracted data that included classification of barriers or enablers, the sub-classification, and the identification of the degree of agency associated with the actor through their role and associations as a mediator within their network, through the application of Actor Network Theory. The data were validated by a second reviewer(PV). Of the 94 studies included, 59 were cross-sectional, 20 were qualitative research, 12 were cohort studies, and three were economic evaluations. Within the review, 51 of the studies included HCP populations and 35 included patients. Policies and guidelines were the most cited group of enablers, overall. Systemic enablers were addressed in 29 studies. For patients, the most frequently cited enabler was positive framing of a biosimilar, while for HCPs, cost benefit was the most frequently noted enabler. The most frequently discussed systemic barrier to biosimilar acceptance was lack of effective policies or guidelines, followed by lack of financial incentives, while the most significant barriers for HCPs and patients, respectively, were their lack of general knowledge about biosimilars and concerns about safety and efficacy. Systemic actors and HCPs most frequently acted with broad degree of agency as mediators, while patient most frequently acted with a narrow degree of agency as mediators within their networks. Barriers and enablers affecting uptake of biosimilars are interconnected within networks, and can be divided into systemic, HCP, and patient categories. Understanding the agency of actors within networks may allow for more comprehensive and effective approaches. Systemic enablers in the form of policies appear to be the most effective overall levers in affecting uptake of biosimilars, with policy makers advised to give careful consideration to appropriately educating HCPs and positively framing biosimilars for patients.

A randomised, crossover trial exploring the patient perspective and effectiveness of biosimilar adalimumab transition: IBD reference and biosimilar adalimumab cross over study (iBaSS).

Patient satisfaction has been positively associated with adherence which is expected to impact outcomes. Although vital for successful implementation of biosimilar medicines, little is known about the patient perspective of transition. The aim of this study was to investigate clinical outcomes and patient experience of transitioning between reference adalimumab and a biosimilar (SB5). iBaSS is a phase IV single-centre, prospective, randomised, single-blind, cross-over study in adult subjects with Crohn's disease. Participants, stable on adalimumab before consent, received 24weeks of treatment with both reference adalimumab and SB5. The primary outcome was the proportion of patients maintaining baseline clinical status throughout each treatment period, with patients' perspective of disease control and treatment satisfaction assessed as secondary outcomes. A total of 112 participants, representative of the heterogeneous patient populations encountered in routine clinical practice, were enrolled. A similar proportion of participants maintained baseline clinical status through each treatment period: 81.8% with reference adalimumab and 79.5% with SB5. Patient reported outcomes (IBD-Control questionnaire (SB5: 15.5; reference adalimumab 15) and TSQM), adverse events and therapeutic drug monitoring remained consistent through both treatment periods, although a higher median injection pain VAS score was noted with SB5 (53/100 versus 6/100 with reference adalimumab). The number of switches undertaken in the study did not impact serum drug concentration or immunogenicity. This study, mimicking real world adalimumab transition, demonstrates that patients undertaking brand transition can be expected to have consistent clinical and satisfaction outcomes. Number 2018-004967-30.

'Totality of Evidence' Approach in the Development of GP2017, an Approved Adalimumab Biosimilar.

Hyrimoz®, (GP2017 [SDZ-ADL]), is a biosimilar to Humira® (REF-ADL). SDZ-ADL was approved in 2018 by both the United States Food and Drug Administration (US FDA) and European Medicines Agency (EMA) for the indications of REF-ADL not protected by orphan exclusivity. In 2023, the US FDA and EMA also approved a citrate-free high-concentration formulation (HCF) of SDZ-ADL. Approval of SDZ-ADL was based on data gathered using the US FDA, EMA and World Health Organization (WHO)-recommended step-wise Totality of Evidence approach. This approach is a robust dataset confirming high confidence in analytical, functional, pharmacokinetic (PK) and clinical biosimilarity between the biosimilar and reference medicine determined through analytical and clinical investigation. Evidence supporting the biosimilarity of SDZ-ADL and REF-ADL was reported at each stage of investigation. Comprehensive comparative analytical and functional assessments demonstrated that SDZ-ADL was analytically indistinguishable from REF-ADL in required critical quality attributes, including receptor binding. Phase I clinical data showed PK similarity of SDZ-ADL and REF-ADL in healthy volunteers, with similar safety, tolerability and immunogenicity profiles. Phase III confirmatory efficacy and safety studies, ADACCESS (included in US/EU dossiers) and ADMYRA (separate to US/EU dossiers), both confirmed that SDZ-ADL's efficacy, safety, and immunogenicity matched REF-ADL in all patient groups with no clinically meaningful differences. More recently, this data package was the basis for a citrate-free HCF of SDZ-ADL to be developed, and its PK, safety and immunogenicity were confirmed against the initially approved formulation of SDZ-ADL. Overall, the Totality of Evidence provided for biosimilar adalimumab, SDZ-ADL, confirmed the analytical, functional and clinical similarity of SDZ-ADL to REF-ADL, supporting its regulatory approval and providing a data bridge with which to evaluate and support the approval of citrate-free HCF SDZ-ADL for clinical use.

A Cross-National Comparison of Biosimilars Pricing in Argentina, Australia, Brazil, and Italy.

Biosimilar medicines are defined as biological products highly similar to an already licensed biological product (RP). The market entry of biosimilars is expected to reduce the costs of biological treatments. This study aims to evaluate the range of differences between the prices of biosimilars and the corresponding RP for biologicals approved in four countries. This is a cross-national comparison of pricing of biosimilars in Argentina, Australia, Brazil, and Italy. The study examined online price databases provided by the national authorities of the investigated countries. Biosimilar price difference was calculated by subtracting the unit price of the biosimilar by the unit price of the RP, and then dividing it by the unit price of the RP. The results were presented as percentage. Brazil had the highest median price reduction (-36.3%) in biosimilars price, followed by Italy (- 20.0%) and Argentina (- 18.6%). All the biosimilars in Italy were priced below the RP presenting a minimum reduction of 6.3%, while in Australia, most of the prices of biosimilars were equal to the RP. In Argentina, one infliximab-biosimilar displayed price above the RP (40.7%) while the lower priced brand had a reduction of 14.4%. Brazil had four biosimilars with prices above the respective RP, including isophane insulin (1), insulin glargine (1) and somatropin (2). The study revealed a marked dispersion in the price's differences between biosimilars and RP across the studied countries. Governments should evaluate whether their policies have been successful in improving affordability of biological therapies.

Plain language review: what are biosimilar medicines and how can they be used to treat people with cancer?

The aim of this plain language review article is to help you to understand biosimilar medicines (called biosimilars) by giving a summary of biologic medicines and biosimilars. It is based on the experience of an international panel of physicians with expertise on biosimilars who discussed and agreed on the topics and information included in this review article. Biologic medicines are medicines that come from living organisms such as bacteria and animal or plant cells. Biosimilars are a group of approved biologic medicines that are similar to original biologic medicines that are already available. This review explains how biosimilars are developed and approved, and how they are used to treat people with cancer. It also answers some common important questions people with cancer might have when taking biosimilars. The purpose of this plain language review is to help you to understand the findings from recent research. This review reports information from peer-reviewed literature and other sources available in the public domain (e.g., regulatory documents or product information labels). The findings may differ from those of other review articles. Health professionals should make treatment decisions based on all available evidence.

A Regulatory Perspective on Biosimilar Medicines.

By definition, biosimilar medicinal products are biological medicinal products that are similar to other biological medicinal products that are already on the market-the reference medicinal products. Access to biosimilar medicines is a current reality. However, to achieve this goal, it is extremely important to consistently and scientifically substantiate the regulatory requirements necessary for biosimilar medicines when accessing the market. Based on an analysis of the raw materials and the type of methods used in the manufacturing processes of biological medicines, it is known that this tends to be more complex for the quality of the finished product than the manufacture of molecules obtained through a chemical process. It is then relevant to highlight the main differences between both products: biological medicines manufactured using biotechnology and the current generics containing active pharmaceutical ingredients (APIs) obtained from synthetic processes. Once arriving at the approval process of these medicinal products, it is imperative to analyse the guidance documents and the regulatory framework that create the rules that allow these biosimilar medicinal products to come to the market. The present review aimed at documenting comparatively the specific provisions of European legislation, through the European Medicines Agency (EMA), as well as the legislation of the United States of America, through the Food and Drug Administration (FDA). This was then translated into a critical appraisal of what concerns the specific criteria that determine the favourable evaluation of a biosimilar when an application for marketing authorisation is submitted to different regulatory agencies. The gathered evidence suggests that the key to the success of biosimilar medicines lies in a more rigorous and universal regulation as well as a greater knowledge, acceptance, and awareness of health professionals to enable more patients to be treated with biological strategies at an earlier stage of the disease and with more affordable medicines, ensuring always the safety and efficacy of those medicines.

P162 The Biosimilar Switch: IBD nurse's experience in Our Lady of Lourdes Hospital

Abstract Background A biological medication contains an active substance that is produced from a biological source such as living cells, hormones or enzymes. The active substance in a biological medicine is what makes the medicine work. Biological medicines are also called biologics. A biosimilar medicine is a biological medicine that is developed to be highly similar to an existing biologic but they are not identical and so cannot be considered to be generics. Biosimilars were introduced in Ireland in 2014. In 2018, Our Lady of Lourdes Hospital commenced a procurement programme to decide which Infliximab biosimilar to switch our patients to. This process would allow for a huge cost-saving to the hospital budget and also allowed for the allocation of a whole-time clinical nurse specialist to add the IBD nursing team. The infliximab biological switch was then carried out starting in October 2019. All patients received a letter explaining the switch and a booklet to explain the meaning of biosimilars. The patients were then either phoned or spoken to in person by either the IBD nurse or a GI pharmacist, and any questions or concerns addressed. Methods A patient satisfaction survey was sent to each patient 6 months after the switch. Each questionnaire was sent with a prepaid return envelope. The questionnaire consisted of 7 questions with tick box answers. 1. Gender? 2. Age? 3. Did you receive a letter and information booklet in the post prior to the day of your infusion switch. 4. Did you get the opportunity to talk to someone on the phone prior to your infusion? 5. Did you get the opportunity to speak to a nurse or pharmacist on the day of your infusion? If so who? 6. Were you given a named person to contact if you had any issues after our first infusion? 7. Were you happy with the overall experience of the infliximab biosimilar switch? Results 86 patients were switched from the originator to the biosimilar Flixabi. 22 responses were received. 1. 11 male; 11 female 2. Age 16-19 - 2; 20-29 - 1; 30-39 - 4; 40-49 - 4; 50-59 - 9; 70-79 - 1; preferred not to answer - 1. 3. 20 received the letter and booklet; 2 did not. 4. 15 spoke to someone on the phone; 6 did not and 1 could not remember. 5. 22 - spoke to a nurse; 0 - pharmacist. 6. 20 - yes; 2 - no. 7. 21 - yes; 1 - unsure. Conclusion Of the 86 patients who were switched 22 responded to the questionnaire. 21 patients were happy with their overall experience with how the switch was conducted.

Capturing the holistic value of biosimilars in Europe – part 1: a historical perspective

ABSTRACT Introduction Approved biosimilars exhibit comparable efficacy, safety, and immunogenicity to reference products. This report provides perspectives on the societal value of biosimilars within Europe and potential factors that have influenced market dynamics. Methods An independent, self-administered survey or one-on-one in-depth interview was used to collect viewpoints about the impact of biosimilar medicines within European markets. Key insights were also sought from an expert panel of European stakeholders. Results Survey respondents were clinicians, pharmacists, and payers from Europe (N = 103). Perceived benefits of biosimilars included increased access to innovative medicines (73% of respondents) or biologic treatments (66%). Biosimilar competition was thought to expand access to biologics (~50% of respondents) or drug combinations (~36%) and reduce biologic access time (34%). Key drivers of biologic access after biosimilar competition included increased biologic awareness (51%) and changes to prescribing guidelines (37%) and/or treatment paradigms (28%). The expert panel developed a market maturity framework of biosimilar adoption/opportunities comprising three stages: ‘Invest,’ ‘Expand,’ and ‘Harvest.’ Findings were supported by published literature. Conclusions In Europe, the perceptions of well-informed survey/interview respondents are that biosimilars have improved patient outcomes via increased access to biologics and innovative biologic products, contributing to earlier and longer treatment of a broader population.

An evaluation of the utilisation of biosimilar monoclonal antibody drugs in Ireland and barriers to their usage.

While biologic drugs have demonstrated efficacy across a range of indications, patient access to these drugs is constrained due to their high cost. Biosimilars provide a means to increase patient access while reducing the financial burden. The primary objective was to determine the current usage of biosimilar and reference trastuzumab and rituximab in four Irish hospitals. A secondary objective involved determining barriers to biosimilar usage. This project involved a retrospective chart review to analyse the usage of reference and biosimilar versions of trastuzumab and rituximab. Additionally, a prospective cross-sectional study identified barriers to the usage of biosimilars via the distribution of a novel questionnaire to patients, pharmacists, doctors and students. The utilisation of biosimilar intravenous trastuzumab and rituximab ranged from 39 to 100%, and 0 to 89%, respectively. A total of n = 479 questionnaire responses were included. Biosimilar awareness was significantly lower among 'Doctors and Medical Students' (45.3%; 95% [CI, 33.8-57.3%]) compared to 'Pharmacists and Pharmacy Students' (97.1%; 95% [CI, 94-98.8%; comparison p < 0.001]). A significant majority of healthcare professionals agreed biosimilars should have consistent nomenclature (p < 0.001). A significant majority of patients (87.3%, 95% [CI, 81.3-92%; p < 0.001]) indicated that they would agree to commence using a biosimilar medicine. Biosimilar versions of trastuzumab and rituximab were in use to a variable extent. There remains a considerable opportunity to further increase the usage to maximise their potential benefits. A series of challenges were identified including reduced awareness among the medical profession and lack of clear nomenclature.

The Introduction of Biosimilar Medicines into Healthcare Systems as a Health Policy Measure to Save Resources: A Major Challenge to Improve the Efficiency of the Greek Healthcare System

The Introduction of Biosimilar Medicines into Healthcare Systems as a Health Policy Measure to Save Resources: A Major Challenge to Improve the Efficiency of the Greek Healthcare System

A plain language summary describing how two different concentrations of GP2017, a biosimilar adalimumab medicine, are associated with similar drug levels within the body.

This plain language summary explains, in simple terms, the results of a study from 2022 discussing a biosimilar medicine called GP2017 (called SDZ-ADL in this summary, sold as Hyrimoz®). This medicine is used to treat people with inflammatory conditions. This study investigated a new, high-concentration formulation of GP2017 (SDZ-ADL-HCF) in order to show that the high concentration option acts the same way in the body as SDZ-ADL. SDZ-ADL-HCF has been submitted for regulatory approval to health authorities on the basis of this study and was recently approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for people with the inflammatory conditions that SDZ-ADL is used to treat. This newly developed formulation provides the option for receiving injections less often with reduced volumes which can have a positive impact on the injection experience and increase patient convenience. This study looked at the pharmacokinetics of SDZ-ADL and SDZ-ADL-HCF, meaning it compared how the active medicine behaved in the body at different times after the injection of each of the formulations. The study also looked at how each formulation was recognized by the body's immune system (known as immunogenicity), and the side effects associated with each formulation. This study was randomly assigned and double-blinded, meaning that neither the participants nor the researchers knew which formulation each participant received. This reduces the risk of bias in the results. The study found that an injection of SDZ-ADL-HCF resulted in similar amounts of the medicine being present within the blood as an injection of SDZ-ADL. This information was needed for the approval of SDZ-ADL-HCF. Participants also experienced similar immune reactions and the number of participants with side effects was similar between both concentrations of medicine. The results confirmed that SDZ-ADL-HCF behaves in the same way in the body and is expected to have the same treatment effects as SDZ-ADL, while at the same time offering an improved formulation with a more positive injection experience and increased patient convenience.

Spanish Society of Hospital Pharmacy position paper on biosimilar medicines

Biological medicines nowadays have a great impact, as they offer treatment for diverse diseases and suppose a high cost for health system. Biosimilar medicines contain a version of an active substance already authorized as an original biotechnological medicine, whose patent has expired, and they comply with the guidelines published by the European Medicines Agency. These guidelines, where biosimilarity criteria are established, guarantee comparability between biosimilar product and reference one. Biosimilars’ authorization is carried out through a centralized procedure based on clinical, non-clinical and quality studies. These studies allow the extrapolation of indications, frequently, without carrying out additional analyses. In several European countries, switching between original and biosimilar medicine is considered safe. In Spain, Pharmacy and Therapeutic Committee of hospitals, as consensus bodies among health professionals, are the most suitable bodies to establish the interchangeability criteria in each center. Biosimilar drugs contribute to sustainability and to improvement of the accessibility to medicines. Faced with this situation, Spanish Society of Hospital Pharmacy considers interesting to express its position about biosimilar medicines’ strategies. Spanish Society of Hospital Pharmacy, in September 2015, published an information note about biosimilar medicines, in which its role as medicines similar in quality, safety and efficacy to the originals, but at lower cost, was highlighted. Likewise, it was stressed the role of hospital pharmacists within the Pharmacy and Therapeutic Committee of hospitals, where their knowledge for the selection, evaluation and use of medicines could be useful, in coordination and permanent collaboration with other units or clinical services of hospitals.

Consensus statement on the use of biosimilar drugs in immune-mediated diseases in Spain

ObjectiveTo improve knowledge about biosimilar medicines and to generate a consensus framework on their use. MethodsQualitative study. A multidisciplinary group of experts in biosimilar medicines was established (1dermatologist, 1hospital pharmacist, 1rheumatologist, and 1gastroenterologist) who defined the sections and topics of the document. A narrative literature review was performed in Medline to identify articles on biosimilar medicines. Systematic reviews, controlled, pre-clinical, clinical, and real-life studies were selected. Based on the results of the review, several general principles and recommendations were generated. The level of agreement was tested in a Delphi that was extended to 66 health professionals who voted from 1 (totally disagree) to 10 (totally agree). Agreement was defined if at least 70% of the participants voted ≥7. ResultsThe literature review included 555 articles. A total of 10 general principles and recommendations were voted upon. All reached the level of agreement established. The document includes data on the main characteristics of biosimilar medicines (definition, development, approval, indication extrapolation, interchangeability, financing, and traceability); published evidence (biosimilarity, efficacy, effectiveness, safety, immunogenicity, efficiency, switch); barriers and facilitators to its use; and data on information for patients. ConclusionsAuthorized biosimilar medicines meet all the characteristics of quality, efficacy, and safety. They also significantly help improve patient access to biological therapies and contribute to health system sustainability.

DRUG POLICY AS PART OF SOCIAL POLICY - CHALLENGES AND SYSTEMIC SOLUTIONS USING THE EXAMPLE OF THE DISSEMINATION OF BIOSIMILAR MEDICINES, EUROPEAN LITERATURE REVIEW

One of the basic functions that the state performs for its citizens is health care. It is carried out through social policy and, in particular, healthcare policy. This article focuses on health and drug policy, addressing the management of biosimilar medicines (biosimilars). These drugs, being cheaper equivalents of expensive original biological drugs (reference drugs), are a tool for managing healthcare expenditure. Their use generates savings for the system and, above all, increases the availability of safe therapies for patients. The purpose of the article is to situate drug policy in social policy, by identifying groups of challenges related to the prevalence of biosimilars and the corresponding European systemic solutions, as part of the implemented drug policy ensuring social security. To achieve the stated objective, a review of the European literature was conducted using search engine PubMed. The time limit was set to five years back (May 25, 2016 - May 25, 2021). The literature indicates that the glue and connecting point between all solutions is an appropriate drug policy implementing the other solutions. The article summarizes solutions used in other countries and organizes them in an innovative way. It can provide inspiration and hints for health care decision-makers, guiding the strategies created to promote the use of biosimilars.

Economic Advantages of Domestic Production of Biosimilar Medicines in Iran

Background: Biosimilars can be considered generic versions of branded biologic medicines. Substituting branded biologic medicines with biosimilars is important to reduce medication costs. In addition to reducing drug costs, the domestic production of biosimilars can provide many other economic benefits. Therefore, this study aimed to investigate the economic benefits of producing biosimilar medicines in Iran.&#x0D; Methods: This study was done in 2021 through 2 qualitative and quantitative steps. In the first step, after literature review, the interview guide was designed and semi-structured interviews with experts continued until reaching the saturation point, after interviewing 9 experts from different fields (imports, production, and policy making). The data were coded and analyzed by thematic analysis using MaxQDA software and the economic benefits of producing the biosimilars in Iran were extracted. In the quantitative step, the price advantage of producing domestic biosimilars was analyzed as one of their most important economic advantages compared to its equivalent in reference countries. In addition, the same comparison was done for the main imported branded medicines.&#x0D; Results: From the experts’ viewpoints, the most important economic effect of the domestic production of biosimilars was the reduction of medication costs through access to lower-priced medicines. The employment of professionals, development of new technologies, expansion of the pharmaceutical market, the reduction of foreign currency outflows, increased affordability and access to drugs, and ultimately the improvement of the health level of the society were the other economic aspects of these medicines. In the quantitative step, after comparing the prices of 23 domestic biosimilars with the prices of the equivalent medicines in reference countries, the prices of 21 medicines were lower than the average prices of equivalent biosimilars and the prices of 18 medicines were even lower than the minimum price of the equivalent biosimilars in the reference countries. In addition, the production of these drugs in the country is indirectly effective in reducing the price of the main branded drugs in the country, so that in the case of imported branded biologic medicines, out of 28 medicines, the prices of 26 medicines were lower than the average prices in the reference countries and the prices of 23 medicines were even lower than the minimum of prices in the reference countries. &#x0D; Conclusion: Based on the results of the study, it was concluded that the domestic production of biosimilar medicines in Iran, in addition to increasing access to biological drugs and promoting public health, provides many economic benefits, including saving drug costs.

A place for biosimilars in the changing multiple sclerosis treatment landscape.

The treatment paradigm for multiple sclerosis (MS), particularly relapsing-remitting MS, is heavily reliant on biologic disease-modifying therapies (DMTs). However, the current cost of treatment acts as a significant barrier to access for patients. Over the next few years exclusivity periods for key biologic medicines used in MS are likely to end, opening the door for biosimilar medicines to enter the market. In this review, we discuss what biosimilar medicines are, and how the existing experience with biosimilar medicines across multiple therapy areas can inform the assimilation of biosimilar medicines into the MS treatment landscape in Europe and the US. There is currently a lack of knowledge and awareness around the distinctions and similarities between small molecules, non-biological complex drugs, and biological medicines, as well as the different categories of follow-on successor medicines. These include biosimilar medicines that offer a matching efficacy and safety profile to the reference biologic. Understanding and recognition of the stringency of the approval pathways required for drug categories such as biosimilars are key in building confidence in treatment outcomes. For example, biosimilar medicines are sometimes perceived only as 'copies' of their reference biologic despite undergoing an extensive approval process requiring that no clinically meaningful differences are observed between the biosimilar medicine and the reference medicine. For MS, introduction of biosimilar medicines in the future will enable more people with MS to receive effective treatment, and also expand access to biologic DMTs in MS. Experiences from the use of biosimilars in multiple therapy areas have shown us that this can result in cost-saving benefits for a healthcare system. Introduction of biosimilar medicines in other therapy areas has also demonstrated the importance of appropriate, accurate education and information for their successful integration into clinical practice. In order to realize optimized treatment outcomes in MS in coming years and to find the appropriate place for biosimilar medicines in the changing MS landscape, it is essential that clinicians and people with MS understand the fundamentals of biosimilars, their potential benefits and consistency of treatment provided by a biosimilar medicine, given the matching efficacy and safety profile to its reference medicine. As evidenced in other therapy areas, biosimilar medicines may reduce key barriers to access by providing a cost-effective alternative to the MS treatment arsenal, while providing the same treatment outcomes as reference biologics.